Hong Kong
Capitalise on the market opportunities in Hong Kong
Product safety requirements and regulations are put in place to reduce risks, improve quality of life and ensure safety during use. These regulations and compliance requirements can however pose challenges to companies who are venturing into the Hong Kong market.
As most products entering the Hong Kong market must meet the relevant requirements of the authorities, it is important to ensure that your products successfully meet the applicable standards, by working with a market leader, TÜV SÜD.
TÜV SÜD fully understands the local requirements and procedures applicable in Hong Kong. You can rely on our expertise and knowledge to help you access key markets efficiently while at the same time, be assured of our objectivity, integrity and professionalism.
Market access information by category
Click on the respective blue bars below to get market access information for each category.
Plug types
Type D | Type G |
Electrical Safety
Electrical Safety
Regulatory agency
Electrical & Mechanical Services Department (EMSD), Government of the Hong Kong Special Administrative Region
Regulations
- All electrical products within the scope of control of the Electrical Products (Safety) Regulation (EPSR) are required to comply with the applicable requirements.
- Prescribed products require certification under an approval regime requiring type testing.
- Non-prescribed products require supplier declarations while certification is also an option.
- Compliance with IEC standards.
EMC
Regulatory agency
Office of the Communications Authority (OFCA)
Regulations
- EMC compliance is required for the above, where applicable.
Electrical Safety & EMC
Guidelines
A local representative is required.
CERTIFICATION PROCEDURE
- Testing to applicable standards should be performed by a recognised CB or recognised manufacturers.
Certificates are issued by a recognised CB, or DoC is issued by recognised manufacturers*.
* Recognised manufacturers are manufacturers who are recognised by EMSD as qualified to issue certificates of safety compliance for the products manufactured by them.
SUPPLIER DECLARATION PROCEDURE
- Manufacturers take responsibility and hold relevant compliance documents for subsequent audits.
- Manufacturers are required to keep test reports for possible request of files.
Applicable product categories
Prescribed products include:
- Adaptors
- Extension units
- Flexible cords
- Lampholders
- Plugs
- Unvented thermal storage type electric water heaters
Non-prescribed products include all other electrical products. To determine if a particular product is subject to the above regulations, please contact us.
Our services at a glance
- TÜV SÜD is a recognised CB able to perform testing and issue certificates to manufacturers.
Energy Efficiency
Regulatory agency
Electrical & Mechanical Services Department (EMSD)
Regulations
- MEELS is applicable for products, namely room air conditioners, refrigerating appliances and compact fluorescent lamps (CFLs), washing machines and dehumidifiers. All these prescribed products for supply in Hong Kong are required to be listed models with reference numbers and must bear energy labels.
- Manufacturers of other products are also encouraged to participate in the voluntary EELS.
Guidelines
- Manufacturers are required to submit product information and test reports to EMSD.
- If accepted, a reference number will be assigned to the product model which will then be included in the EMSD record.
Applicable product categories
Product categories under the mandatory EELS include:
- Air conditioners
- Compact fluorescent lamps
- Dehumidifiers
- Refrigerating appliances
- Washing machines
To determine if a particular product is subject to the above regulations, please contact us.
Our services at a glance
TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Hong Kong requirements and obtaining the necessary approval. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels.
Medical Devices
Regulatory agencies
- Medical Device Control Office (MDCO) & Department of Health (DOH)
Regulations
- The regulatory framework is largely in line with that recommended by the International Medical Device Regulators Forum (IMDRF).
- Under the MDACS*, manufacturers of Class II, III and IV devices can voluntarily list products with the DOH after obtaining a conformity assessment certificate or marketing approval from other countries which have adopted the GHTF model.
- Conformity assessment can be conducted by MDCO- recognised CAB.
- Manufacturers and importers must also be listed online.
* There is currently no specific legislative control over the importation and sale of medical devices in Hong Kong. An administrative control system called Medical Device Administrative Control System (MDACS) has been set up to facilitate the transition to long-term statutory control.
Guidelines
- A Local Responsible Person (LRP) is required.
- Conformity includes a quality management system, a post-market surveillance system, technical documentation and a DoC.
- The list of devices will be posted on the MDCO website.
Applicable product categories
To determine if a particular product is subject to the above regulations, please contact us.
Our services at a glance
TÜV SÜD is recognised by the DOH as a CAB under the MDACS.